Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi for HFrEF - DIAMOND

Aug 15, 2022
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Vifor Pharma
Date Presented:
04/03/2022
Date Published:
07/28/2022
Date Updated:
08/15/2022
Original Posted Date:
04/03/2022
References

Contribution To Literature:

Highlighted text has been updated as of August 15, 2022.

The DIAMOND trial showed that patiromer was effective at maintaining lower serum potassium levels among patients with heart failure with reduced ejection fraction (HFrEF).

Description:

The goal of the trial was to evaluate patiromer compared with control among patients with HFrEF and history of hyperkalemia.

Study Design

  • Randomized
  • Parallel

Patients with HFrEF and hyperkalemia were randomized to patiromer (n = 439) vs. control (n = 439). Prior to randomization, eligible patients had a run-in phase during which time patiromer was started, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor–neprilysin inhibitor optimized, and mineralocorticoid receptor antagonist (MRA) initiated/optimized. After the run-in phase, patients were randomized to continue patiromer vs. stop patiromer. 

  • Total number of enrollees: 878
  • Duration of follow-up: 13 weeks
  • Mean patient age: 67 years
  • Percentage female: 26%
  • Percentage with diabetes: 42%

Inclusion criteria:

  • HFrEF (left ventricular ejection fraction ≤40%)
  • New York Heart Association class II-IV symptoms
  • On beta-blocker or unable to tolerate beta-blocker
  • Current or history of hyperkalemia

Exclusion criteria:

  • Acute decompensated HF
  • Estimated glomerular filtration rate <30 mL/min/1.73 m2
  • Systolic blood pressure <90 mm Hg
  • Major cardiovascular event within the last 4 weeks

Other salient features/characteristics:

  • Mean serum potassium: 4.6 mEq/L
  • During the run-in phase, 85% of participants were able to be optimized on guideline-directed doses of renin–angiotensin–aldosterone system inhibitors (RAASi)

Principal Findings:

The primary outcome, adjusted mean change in serum potassium from randomization to study end, was 0.03 mEq/L in the patiromer group vs. 0.13 mEq/L in the control group (p < 0.001).

Secondary outcomes:

  • Serum potassium >5.5 mEq/L: 13.9% in the patiromer group vs. 19.4% in the control group (p = 0.006)
  • Reduction in MRA dose below target: 13.9% in the patiromer group vs. 18.9% in the control group (p = 0.006)
  • Hyperkalemia-related outcomes win-ratio: ratio 1.53 (p < 0.001)
  • RAASi use-score win-ratio: ratio 1.25 (p = 0.048)

Interpretation:

Among patients with HFrEF and history of hyperkalemia, patiromer was beneficial. Patiromer was able to maintain lower serum potassium levels and was associated with a lower incidence of severe hyperkalemia (>5.5 mEq/L) compared with control. Patiromer allowed for 85% of participants to be optimized on guideline-directed medical doses of RAASi.

References:

Butler J, Anker SD, Lund LH, et al. Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial. Eur Heart J 2022;Jul 28:[Epub ahead of print].

Presented by Dr. Javed Butler at the American College of Cardiology Annual Scientific Session (ACC 2022), Washington, DC, April 3, 2022.

Clinical Topics: Heart Failure and Cardiomyopathies, Prevention, Acute Heart Failure, Heart Failure and Cardiac Biomarkers

Keywords: ACC22, ACC Annual Scientific Session, Adrenergic beta-Antagonists, Angiotensin Receptor Antagonists, Angiotensin-Converting Enzyme Inhibitors, Heart Failure, Hyperkalemia, Mineralocorticoid Receptor Antagonists, Neprilysin, Potassium, Receptors, Angiotensin, Renin-Angiotensin System, Secondary Prevention, Stroke Volume, Ventricular Function, Left


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